IMBRUVICA™ (ibrutinib) approved to treat Chronic Lymphocytic Leukemia; Diplomat Specialty Pharmacy to distribute
Flint, Mich. – Feb. 12, 2014 — Diplomat, the country’s largest independent specialty pharmacy, announced today that IMBRUVICA™ (ibrutinib) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic lymphocytic lymphoma (CLL) in patients who have received at least one prior therapy. An improvement in survival or disease-related symptoms has not been established.
IMBRUVICA™, a Bruton’s tyrosine kinase (BTK) inhibitor, is an oral drug available in 140 mg, 90 capsule bottles and 140 mg, 120 capsule bottles. Recommended dosage of IMBRUVICA™ for CLL is 420 mg (three 140 mg capsules) orally, once daily. Full prescribing information is available at www.IMBRUVICA.com.
“Relapsed or refractory chronic lymphocytic leukemia can be challenging to treat and therapy options currently available are not ideal for all patients,” said Gary Rice, RPh, MS, MBA, CSP, Vice President of Clinical Services at Diplomat. “IMBRUVICA™, a once-daily oral medication, represents a major achievement in drug development and an important option for patients with this disease.”
Diplomat is currently distributing IMBRUVICA™ for the treatment of mantle cell lymphoma (MCL). IMBRUVICA™ was approved by the FDA in Nov 2013 for the treatment of MCL in patients who have received prior therapy for the disease under the breakthrough therapy designation.
Diplomat’s high-tech, high-touch approach, which achieved 98% patient and prescriber satisfaction ratings in 2012, includes timely prescription delivery, side effect management support and 24 hour access to pharmacists and other specialists on the continuum of care. For IMBRUVICA™, Diplomat will also provide prior authorization management, co-pay support and assistance to patients that meet certain financial criteria.
IMBRUVICA™ is commercially available immediately.
Media contacts: Barbara Fornasiero, EAFocus Communications: 586.817.8414, firstname.lastname@example.org. Jim Kosmerick, Director of Marketing, Diplomat: 810.768.9530, JKosmerick@diplomat.is. Gary Rice, RPh, MS, MBA, CSP, Vice President of Clinical Services,Diplomat: 810.768.9863, GRice@diplomat.is.
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